1. Field of the Invention
The invention relates generally to introducers, sheaths, guides or catheters and hemostatic valves, and more specifically to a nonfrangible guide or introducer and hemostatic valve combination and the method of using the same.
2. Description of the Prior Art
For purposes of this specification a sheath is defined as an un-reinforced hollow tube, which may contain lines of weakness to aid in the peeling apart of the sheath.
A guide is a braid-reinforced hollow tube that cannot be peeled, or torn away simply by pulling on it, but must be sliced or cut open with a cutter, slicer, slitter or other tool. Further, while the guide is disclosed as braided, any construction of the guide, which allows the guide to be torsionally stiff enough such that a rotation of its proximal end is transmitted in its substantial entirety to its distal end when the guide is in use, is considered equivalent. Thus, the guide is termed, “nonfrangible”.
A catheter is a general term used to describe a tube that may be braided or not, and is generally used to inject or aspirate fluids.
An introducer is a general term used to describe a sheath or guide that is used to introduce another medical device into the body.
The prior art has a variety of guides, introducers and catheters in combination with hemostatic valves, wherein the catheters or introducers are of the frangible type. Most of these prior art devices also require introducers that are of a stiffer material to aid in insertion of a catheter sheath into a patient's vein.
Of particular interest is U.S. Pat. No. 6,083,207 to Heck, which is incorporated herein by reference. Heck's device incorporates a frangible introducer. Morris, U.S. Pat. No. 5,713,867 is directed to a braided introducer having a pair of symmetrically opposed tabs on its proximal end, which introducer is slit by a cutting tool or is torn along a weakened line. The tabs remain permanently affixed to each longitudinal half of the introducer. Morris does not clearly describe or show how the cutting tool is used to cut through the hub or the structure, which forms the base structure which connects the tabs to the introducer. In fact, it is believed that Morris is inoperable to function as a splittable introducer due to the barrier presented by the hub to any cutting step.
The frangible sheaths of the prior art cannot torqued as required to steer the distal end of the sheaths, namely to be steered through the subclavian vein into the right atrium, through the right ventricle, and into the pulmonary artery. This and other steering requirements necessitate that the sheath be reinforced to transmit the torsional forces applied to its proximal end to its distal end during guiding.
The prior art is further deficient in that it lacks an adequate showing or disclosure relating to removable or openable hemostatic valves directly and integrally connected to a guide.
The prior devices are also lack hemostatic valve bodies having weakened lines along which the valve body may be broken into at least two portions, wherein one of the portions are integrally connected with the introducer and one separable to allow for cutting of the reinforced introducer.
While the prior art shows some hemostatic valve bodies that open on a hinge, the prior art fails to show such valve bodies directly connected to a guide.